![TOPCARE HEMORRHOIDAL (COCOA BUTTER, PHENYLEPHRINE HCL) SUPPOSITORY [TOPCO ASSOCIATES LLC]](https://medic.hrt.org//dailymed/images/81a3546b-5099-4b9a-b774-b3e79316b267/279 88 hemorrhoidal-suppositories-image.jpg)
| NDC | 36800-279-53, 36800-279-62 |
| Set ID | 81a3546b-5099-4b9a-b774-b3e79316b267 |
| Category | HUMAN OTC DRUG LABEL |
| Packager | Topco Associates LLC |
| Generic Name | |
| Product Class | alpha-1 Adrenergic Agonist |
| Product Number | |
| Application Number | PART346 |
- Active ingredients (in each suppository)
- Purposes
-
Uses
- •
- helps relieve the local itching and discomfort associated with hemorrhoids
- •
- temporarily relieves burning and shrinks hemorrhoidal tissue
- •
- temporarily provides a coating for relief of anorectal discomforts
- •
- temporarily protects the inflamed, irritated anorectal surface to help make bowel movements less painful
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Warnings
For rectal use only
Ask a doctor before use if you have
- •
- heart disease
- •
- high blood pressure
- •
- thyroid disease
- •
- diabetes
- •
- difficulty in urination due to enlargement of the prostate gland
Ask a doctor or pharmacist before use if you are
presently taking a prescription drug for high blood pressure or depression.
- Keep out of reach of children.
-
Directions
- •
- adults: when practical, cleanse the affected area by patting or blotting with an appropriate cleansing wipe. Gently dry by patting or blotting with a tissue or a soft cloth before insertion of this product.
- •
- detach one suppository from the strip; remove the foil wrapper before inserting into the rectum as follows:
- •
- hold suppository with rounded end up
- •
- see illustrations: carefully separate foil tabs by inserting tip of fingernail at end marked “peel down”
- •
- slowly and evenly peel apart (do not tear) foil by pulling tabs down both sides, to expose the suppository
- •
- remove exposed suppository from wrapper
- •
- insert one suppository into the rectum up to 4 times daily, especially at night, in the morning or after each bowel movement
- •
- children under 12 years of age: ask a doctor
- Inactive ingredients
-
Package/Label Principal Display Panel
COMPARE TO PREPARATION H® HEMORRHOIDAL SUPPOSITORIESACTIVE INGREDIENTS
NIGHTTIME RELIEF
Hemorrhoidal Suppositories
OUR PHARMACISTS RECOMMEND
Reduces Internal Swelling. Soothes and Protects
Prompt Soothing Relief from Painful Burning, Itching and Discomfort
Shrinks Swollen Hemorrhoidal Tissue
Protects Irritated Tissue
E – Z OPEN WRAPPER
12 SUPPOSITORIES
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INGREDIENTS AND APPEARANCE
TOPCARE HEMORRHOIDAL
cocoa butter, phenylephrine hcl suppositoryProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:36800-279 Route of Administration RECTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength COCOA BUTTER (UNII: 512OYT1CRR) (COCOA BUTTER - UNII:512OYT1CRR) COCOA BUTTER 2211 mg PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 6.5 mg Inactive Ingredients Ingredient Name Strength METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLPARABEN (UNII: Z8IX2SC1OH) STARCH, CORN (UNII: O8232NY3SJ) Product Characteristics Color YELLOW (light) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:36800-279-62 24 in 1 CARTON 11/03/2014 1 1 in 1 BLISTER PACK; Type 0: Not a Combination Product 2 NDC:36800-279-53 12 in 1 CARTON 11/03/2014 2 1 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part346 11/03/2014 Labeler - Topco Associates LLC (006935977)
